(138 days)
The CIC Pro Clinical Information Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment.
CIC Pro Clinical Information Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information.
Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Clinical Information Center Central Station supports the ability to access information from CIC Pro Clinical Information Center Central Station' products in a web browser format. Additionally, CIC Pro Clinical Information Center Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.
The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients. Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device K053356.
It's important to note that the provided 510(k) summary is for a "Central Station Monitoring System," and the "acceptance criteria" and "study" described are centered around software and system validation, not clinical performance metrics typical of AI/ML devices. This document does not describe the kind of performance study you'd expect for an AI diagnostic tool.
Acceptance Criteria and Device Performance for K053356: CIC Pro Clinical Information Center Central Station
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Technology | Employs the same functional technology as the predicate devices. |
| Voluntary Standards Compliance | Complies with voluntary standards detailed in Section 9 of the submission. |
| Quality Assurance Measures | - Requirements specification review was applied. - Code inspections were applied. - Software and hardware testing was applied. - Safety testing was applied. - Environmental testing was applied. - Final validation was applied. |
| Overall Equivalence | Demonstrated to be as safe, as effective, and performs as well as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical cases. The "testing" mentioned refers to software and hardware testing, safety testing, and environmental testing of the device itself. Therefore, information about sample size for a test set of patient data, data provenance (country of origin, retrospective/prospective), or ground truth is not applicable in the clinical sense for this submission. The validation is focused on system functionality and regulatory compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the submission does not describe a clinical performance study using patient data and expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the submission does not describe a clinical performance study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices to evaluate human performance with and without AI assistance. The CIC Pro is a central monitoring station, not a diagnostic AI tool, and its submission focuses on system functionality and equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is not applicable in the context of this device. The CIC Pro is a display and monitoring system that processes and presents existing physiological data. It does not embody an "algorithm" in the sense of a standalone diagnostic or interpretive AI. Its performance is evaluated on its ability to correctly collect, display, and print data as per its intended use and compliance with standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is primarily defined by:
- Predicate Device Performance: The primary "ground truth" or benchmark is the performance of the legally marketed predicate device (K032370 Clinical Information Center (CIC) Central Station). The new device aims to be "as safe, as effective, and performs as well as" the predicate.
- Requirements Specifications: The device's performance is measured against detailed requirements specifications for its hardware and software functions.
- Voluntary Standards: Compliance with relevant industry and regulatory voluntary standards (detailed in Section 9, though not provided in this extract).
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical efficacy study.
8. The Sample Size for the Training Set
This information is not applicable. The CIC Pro is a non-AI/ML medical device submission. It does not describe a "training set" in the context of machine learning model development. The development process involved "requirements specification review," "code inspections," "software and hardware testing," etc., but not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or machine learning model development. The ground truth for the device's development and validation relied on engineering specifications, regulatory standards, and comparison to the predicate device.
Summary of the Study Performed (as per provided text):
The "study" described for the K053356 CIC Pro Central Station is primarily a System Validation and Equivalence Study. It focuses on demonstrating that the new device shares the "same functional technology" as its predicate device and that its development followed established quality assurance measures.
The study included:
- Compliance Verification: Ensuring the device and its applications comply with relevant voluntary standards.
- Quality Assurance Process Implementation: Application of standard software and hardware development quality measures, including:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
- Predicate Device Comparison: The ultimate conclusion of the study was that these measurements "demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device."
This type of submission emphasizes engineering validation and regulatory compliance rather than clinical performance metrics from a patient-data study typical of diagnostic or AI-driven devices.
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510(k) Summary of Safety and Effectiveness
| Date: | November 28, 2005 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Ronald N. BlaskiRegulatory Affairs SpecialistGE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USAPhone: 414-362-2348Fax: 414-362-2585 |
| Device: Trade Name: | CIC Pro Clinical Information Center Central Station |
| Common/Usual Name: | Central Station Monitoring System |
| Classification Names: | |
| 21 CFR 870.2450 | Display, Cathode-ray Tube, Medical DXJ |
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia DSI |
| Predicate Device: | K032370 Clinical Information Center (CIC) Central Station |
| Device Description: | The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients. |
| Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer. | |
| Intended Use: | The CIC Pro Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. |
| The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information. | |
| Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. | |
| The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server. |
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The CIC Pro Central Station employs the same functional technology Technology: as the predicate devices.
Test Summary: The CIC Pro platform and its applications comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- . Requirements specification review
- . Code inspections
- . Software and hardware testing
- . Safety testing
- . Environmental testing
- . Final validation
Conclusion:
The results of these measurements demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukce, WI 53223
Re: K053356 Trade Name: CIC Pro Clinical Information Center Central Station, Version 5 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: Undated Received: April 17, 2006
Dear Mr. Blaski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ronald N. Blaski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummenhof
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K053356
Device Name: CIC Pro Clinical Information Center Central Station
Indications for Use:
The CIC Pro Clinical Information Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment.
CIC Pro Clinical Information Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information.
Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Clinical Information Center Central Station supports the ability to access information from CIC Pro Clinical Information Center Central Station' products in a web browser format. Additionally, CIC Pro Clinical Information Center Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.
Prescription Use - -X (Part 21 CFR 801 Subpart D)
ANDAOR
(Over-The-Counter Use -(21 CFR 801 Subpart ( )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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Bhemnnch
(Posted November 13, 2003)
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).